Phase 3
Completed N=644
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Source: ClinicalTrials.gov NCT05403827 ↗Enrolled (actual)
644
Serious AEs
0.9%
Results posted
Jan 2025
Primary outcomePrimary: Change in EDS (VAS) From Baseline to Day 85 — -18.0; -19.4 mm — p=0.5019
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in EDS (VAS) From Baseline to Day 85 |
-18.0; -19.4 | 0.5019 |
| PRIMARY Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye) |
-2.81; -3.25 | 0.2028 |
| SECONDARY Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye) |
-4.73; -5.44 | 0.1914 |
| SECONDARY Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye) |
-1.92; -2.19 | 0.2512 |
| SECONDARY Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©) |
-14.12; -14.17 | 0.7906 |
| SECONDARY Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye) |
2.4; 2.6 | 0.5343 |
| SECONDARY Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye) |
0.580; 0.520 | 0.3757 |
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years of age at the time of Informed Consent
- Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom
- Meet all other inclusion criteria outlined in the clinical study protocol
Exclusion Criteria
- Have any clinically significant ocular condition
- Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months
- Meet any other exclusion criteria outlined in the clinical study protocol
Data sourced from ClinicalTrials.gov (NCT05403827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.